A Pilot Study to Assess the Efficacy and Tolerability of Reduced Dose Oral Iron in the Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease Patients.

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Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD.

2023-10-20

2024-10-01

2025-10-01

Recruiting

Early phase I

30

Inclusion Criteria: * Patient is willing to participate in the study and has signed the informed consent. * Patients aged 18-80 years. * Patients diagnosed with Crohn's disease or ulcerative colitis diagnosed by conventional clinical, radiological and histological criteria. * Remission or active disease. * Haemoglobin level 7-13 g/dL men, 7-12 g/dL women and ferritin \<30, normal B12 and folate (or ferritin \<100 but iron sats \<16 in the presence of inflammation defined as CRP\>5mg/L, faecal calprotectin\>250 microgram/g and presence of endoscopic inflammation). Exclusion Criteria: * Patients under 18 or unable to give informed consent. * Patients with advanced liver disease. * Patients with advanced renal disease with eGFR\<45ml/min * Previous intolerance to even low doses of oral iron * Patients with severe cardiovascular disease defined as previous unstable angina and or previous MI without intervention. * Participation in other trials in the last 3 months. * Serious inter-current infection or other clinically important active disease (including renal and hepatic disease) and recently diagnosed gastrointestinal tract cancers * Pregnant, post-partum (\<3months) or breast feeding females * Erythropoietin therapy. * Recent blood transfusion within 30 days. * Recent iron infusion within 30 days.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is an adaptive, open label study to compare the efficacy and tolerability of 8 weeks of low dose oral iron, in the treatment of iron deficiency anaemia in patients with inflammatory bowel disease (IBD).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-03-20